|Publication number||US9232940 B2|
|Application number||US 13/794,180|
|Publication date||12 Jan 2016|
|Filing date||11 Mar 2013|
|Priority date||22 Oct 2008|
|Also published as||EP2373225A1, EP2373225B1, US8394112, US20100114123, US20130190782, WO2010048420A1|
|Publication number||13794180, 794180, US 9232940 B2, US 9232940B2, US-B2-9232940, US9232940 B2, US9232940B2|
|Inventors||Kevin S. Nason|
|Original Assignee||Cayenne Medical, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (49), Non-Patent Citations (1), Classifications (13), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This U.S. Utility Patent Application is a divisional application under 35 U.S.C. 120 of commonly assigned U.S. patent application Ser. No. 12/604,190 entitled Arthroscopic Suture Passin Devices and Methods filed Oct. 22, 2009, and issuing on Mar. 12, 2013 as U.S. Pat. No. 8,394,112, which in turn claims the benefit under 35 U.S.C. 119(e) of the filing date of U.S. Provisional Patent Application Ser. No. 61/107,637, entitled Arthroscopic Suture Passing Device, filed on Oct. 22, 2008, the contents of each of which are expressly incorporated herein by reference in their entirety.
This invention relates generally to methods and apparatus for repairing soft tissue arthroscopically, and more particularly to methods and apparatus for passing suture through soft tissue.
There are many procedures, such as capsular plication, Bankart lesion repairs, or reconstruction of labral tissue to the glenoid rim, in which a practitioner needs to secure tissue in close contact with bone. Suture is passed through soft tissue, the bone surface is roughened, and when tissue is pulled into intimate contact, the body's healing response will fuse the tissue and bone together.
Such procedures are often accomplished by implanting an anchor, pre-loaded with a strand of suture, into a hole drilled in the bone at a desired anchor location. One or both of the suture ends are then passed through soft tissue at the desired location, the tissue is pulled close to the bone at the anchor site, and the suture is secured to the anchor by tying a knot.
There are many suture passing devices on the market today, which are intended to pass suture through soft tissue. Some are designed for specific locations—i.e. devices like the Arthrex VIPER and SCORPION, which are designed to grasp rotator cuff tissue and pass a suture perpendicularly through it. Using these types of devices, the surgeon captures the edge of the tissue in the jaws of a grasper, which stabs a needle, carrying suture, through the rotator cuff tissue. The suture is then retrieved with a grasper. However, this device cannot pass suture multiple times without reloading the device. Also, since they are optimized for rotator cuff tissue, they cannot reach many of the areas within the gleno-humeral joint space.
More general suture passer designs consist of a needle bent into several curved shapes at the sharp end. The curves differ in angle of bend, direction of curve, and shape of curve, to allow the surgeon to reach as many locations within the joint as possible. The surgeon plunges the tip of the needle into tissue at one location and back out of the tissue at another. Suture is then “shuttled” through the needle. The needle is removed and the suture remains, passing through the tissue at the desired location.
The Conmed Linvatec Spectrum suture passing device is a general purpose suture passing device that comes with several different suture hook variations to allow for access to multiple locations within the joint. This device can use monofilament suture for shuttling or a dedicated suture lasso. In an effort to eliminate suture shuttling, Conmed has recently released the Spectrum MVP product. This device adds a tube which runs alongside the curved needle. The curved needle is passed through the tissue. A nitinol suture snare is then deployed from inside the tip of the curved needle, which opens to form a loop. A piece of suture, which is loaded onto the tip of the straight tube, is pushed forward and through the loop by a nitinol push-rod. The snare is closed around the suture and push-rod, capturing the suture. The curved needle is then pulled back through the tissue, bringing the suture along with it and out of the joint. Although this new device eliminates the shuttling step, it must be passed completely through the tissue (in order to deploy the nitinol snare) and it can only make one suture pass at a time. It must be removed from the joint and reloaded with suture for each pass. Also, if the joint space is small, the nitinol loop may not be able to fully open or may get pushed to the side. In this case, it may no longer line up with the nitinol push-rod and be able to capture the suture.
There are several methods of “shuttling” suture once the needle is passed through the tissue. Since it is difficult to push suture down the long needle, often a “suture shuttle” is passed down the shaft and out the end of the needle where it is grasped by an arthroscopic grasper, often introduced into the joint space through another portal. One end of the suture shuttle is pulled out of the joint space, attached to a free end of the suture that will remain in the body, then pulled back through the tissue. This pulls the suture back through the hole, where it is then used to secure the tissue to the desired location, often an anchor. Common suture shuttles are monofilament suture (which is tied around the high-strength suture to pull it back through the tissue), monofilament suture loops to snare the suture, or dedicated snares made of nitinol wire.
One of the most difficult steps in passing suture through soft tissue with existing devices is piercing the needle completely through the tissue. Piercing the needle tip into the tissue is usually not difficult. However, getting the tip of the needle back out of the tissue so that the suture shuttle can be passed out of the end can be difficult, especially if the tissue is very soft. This is often the case in the inferior capsule of the shoulder. An important step in reducing laxity of the shoulder, called capsular plication or capsular shift, is passing suture through capsular tissue inferior to the glenoid. This tissue is often very soft and does not provide enough tension to resist the needle and allow the tip to pierce back out of the tissue.
Arthrex, TAG, and several other companies also make suture passers which operate slightly differently, and do not require suture shuttling. Arthrex's version, the Birdbeak, resembles a sharply pointed set of suture graspers. The device is pierced through the tissue, grasps suture already in the joint space (usually attached to an anchor), and pulls the suture back through the tissue. These devices do not require suture shuttling and can, theoretically, pull sutures through different locations without removing the device from the joint space. However, mobility of the device is severely limited once it has been pierced through the tissue. This requires the suture to be in the correct location to be grasped. This is often accomplished by holding and manipulating the suture with a grasper placed into the joint through a second working portal.
The invention described and shown herein is intended to make passing suture through soft tissue easier for a practitioner. The devices currently used for this type of procedure are generally called suture passing devices or suture passers. The new device of the invention addresses multiple issue present in currently marketed devices. The new device does not require the suture passer to be completely passed through (into or out of) the tissue, does not require suture shuttling, has the ability to pass suture multiple times through tissue without removing the device from the joint space or reloading suture, and operates through a single arthroscopic working portal. Practitioners using the systems and methods of this invention do not need to bring the tip of the needle back out of the tissue in order to pass suture. By using two needles which meet at the tips, the surgeon simply pierces the curved needle tip into the tissue, advances the second needle—which meets up with the tip of the curved needle—and passes suture between them. This eliminates the most technically difficult parts of the prior art procedures.
Another improvement over currently marketed devices is the elimination of suture shuttling. Suture shuttling is a very tedious process which takes a great deal of time during the procedure. As stated previously, the tip of the needle must pierce into and completely out of the tissue in order to push the suture shuttle out of the tip. Even if there is a small film of tissue over the hole in the end of the needle, the suture shuttle will not pass through. Also, the practitioner must grasp the end of the suture shuttle and pull it out of the joint space. With many sutures in the way and a tight joint space, this can be challenging. Problems can occur when pulling the suture back through the hole in the tissue. Monofilament suture, often tied with a knot around the suture, can break, or the knot can untie when pulling the suture back through the tissue. This often requires the entire suture passing procedure to be repeated. Suture can slip out of monofilament loops, and dedicated nitinol snares are expensive. Finally, suture shuttling takes considerable operating room time. A common Bankart repair utilizing three anchors, each with a mattress stitch through nearby tissue, requires six separate suture shuttling procedures. This can easily take 10 or 12 minutes of a 30-40 minute surgery.
Yet another time consuming step with existing devices and methods involves removing and re-inserting the device into the joint space with each suture shuttle step. After the shuttle is passed through the tissue, the suture passing device is removed from the joint space, the suture is shuttled, and the device re-inserted for the next suture pass. This new device can make multiple suture passes through the tissue without shuttling suture or removing the device between each one. During a shoulder plication, this allows the surgeon to quickly make multiple pleats in the tissue to optimize the direction and amount of capsular tightening—something that would be very difficult and time consuming with existing approaches.
Additionally, the inventive system can pass suture multiple times through a single cannula. Many of the other devices in the prior art require (or are helped considerably by) a grasper or other suture manipulating instrument in the joint space. Using multiple devices simultaneously requires more than one working portal. By using a single portal approach, the practitioner may be able to make the surgical procedure considerably less invasive for the patient.
More particularly, there is provided a system for transdermal repair of soft tissue, which includes an instrument comprising a proximal actuator portion, a fixed needle having a lumen and extending distally from the proximal actuator portion, and a movable needle having a lumen and extending distally from the proximal actuator portion. The movable needle is movable axially between an advanced position and a retracted position relative to the proximal actuator portion. A suture needle is disposed within the lumen of one of the fixed and movable needles, and has a length of suture connected thereto. A needle grasper is disposed in the lumen of the aforementioned one of the fixed and movable needles, proximally of the suture needle, and has grasper jaws disposed on a distal end thereof which are movable between a closed orientation and an open orientation. The grasper jaws are adapted for securing a first end of the suture needle.
A second needle grasper is disposed in the lumen of the other of the fixed and movable needles, and has grasper jaws disposed on a distal end thereof which are movable between a closed orientation and an open orientation. The grasper jaws on the second needle grasper are adapted for securing a second end of the suture needle.
Preferably, the suture needle comprises a flexible wire having a first collar disposed at the first end and a second collar disposed at the second end. The collars provide a means for the grasper jaws of each of the needle graspers to readily engage the suture needle ends. A coil on the suture needle is slidable therealong, and the length of suture is connected to the coil.
In the preferred embodiment, the fixed needle is curved at a distal end thereof, and the movable needle is straight.
An actuator is provided on the actuator portion for axially moving the movable needle. A second actuator on the actuator portion functions to move the suture needle between the movable needle and the fixed needle.
To actuate the grasper jaws on each grasper between their open and closed orientations, the lumen in the aforementioned one of the fixed and movable needles has a smaller diameter portion and a larger diameter portion, with the larger diameter portion being distal to the smaller diameter portion, so that as the needle grasper moves distally within the lumen of that needle, it moves from the smaller diameter portion, wherein the grasper jaws are forced into their closed orientation to clamp the first end of the suture needle in place, to the larger diameter portion, at which time the grasper jaws move to their open orientation to release the first end of the suture needle. Similarly, the lumen in the other of the fixed and movable needles has a smaller diameter portion and a larger diameter portion, the larger diameter portion being distal to the smaller diameter portion, so that as the second needle grasper moves proximally within the lumen of the other of the fixed and movable needles, it moves from the larger diameter portion, wherein the grasper jaws are released into their open orientation, to the smaller diameter portion, at which time the second grasper jaws are forced into their closed orientation to clamp the second end of the suture needle in place. The needle graspers are movable, respectively, relative to the needle in which they are disposed and within the lumen of that needle.
In another aspect of the invention, there is provided a system for transdermal repair of soft tissue, which includes an instrument comprising a proximal actuator portion, a curved needle having a lumen and extending distally from the proximal actuator portion, and a movable straight needle having a lumen and extending distally from the proximal actuator portion, wherein the movable needle is movable axially between an advanced position and a retracted position relative to the proximal actuator portion. A suture needle is disposed within the lumen of one of the straight and curved needles, and has a length of suture connected thereto. A needle grasper is disposed in the lumen of the aforementioned one of the straight and curved needles, proximally of the suture needle, and has grasper jaws disposed on a distal end thereof which are movable between a closed orientation and an open orientation. The grasper jaws are adapted for securing a first end of the suture needle, and the needle grasper is axially movable within the lumen of the one of the straight and curved needles, relative to that needle. A second needle grasper is disposed in the lumen of the other of the straight and curved needles and has grasper jaws disposed on a distal end thereof which are movable between a closed orientation and an open orientation. The second needle grasper jaws are adapted for securing a second end of the suture needle. The second needle grasper is axially movable within the lumen of the other of the straight and curved needles, relative to that needle.
The suture needle preferably comprises a flexible wire having a first collar disposed at the first end and a second collar disposed at the second end. The grasper jaws of each of the needle graspers may readily engage the collars to secure the suture needle. A coil is provided on the suture needle which is slidable therealong, wherein the length of suture is connected to the coil. An actuator on the actuator portion axially moves the movable straight needle, and a second actuator on the actuator portion moves the suture needle between the movable straight needle and the curved needle.
To actuate the grasper jaws on each grasper between their open and closed orientations, the lumen in each of the straight and curved needles has a smaller diameter portion and a larger diameter portion, the larger diameter portion being distal to the smaller diameter portion. With this construction, as the needle grasper in each respective needle moves distally within the lumen of that needle, it moves from the smaller diameter portion, wherein the grasper jaws are forced into their closed orientation to clamp one of the ends of the suture needle in place, to the larger diameter portion, at which time the grasper jaws move to their open orientation to release that suture needle end. As the needle grasper in each respective needle moves proximally within the lumen of that needle, it moves from the larger diameter portion, wherein the grasper jaws are released into their open orientation, to the smaller diameter portion, at which time the grasper jaws are forced into their closed orientation to clamp the suture needle end in place.
In still another aspect of the invention, there is disclosed a method of repairing soft tissue, which comprises steps of introducing an instrument having a curved needle and a movable straight needle, each extending distally from a proximal actuator portion, into an operative site, piercing tissue to be sutured with a distal end of the curved needle, and advancing the straight needle until a distal end thereof lines up with and meets the distal end of the curved needle. A suture needle, disposed in one of the curved and movable straight needles, is then passed from one of the curved and movable straight needles to the other one of those needles. The movable straight needle is then retracted proximally, and the curved needle is pulled back through the tissue, thereby creating a stitch of suture in the tissue.
In the above described method, the suture needle is initially clamped on one end by a grasper disposed in the aforementioned one of the curved and movable straight needles, and the passing step comprises moving the grasper distally to push the suture needle out of the one of the curved and movable straight needles and into the other of the curved and movable straight needles. The passing step further comprises releasing the one end of the suture needle from the grasper and clamping the other end of the suture needle using a second grasper disposed in the other of the curved and movable straight needles.
The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawing.
Referring now more particularly to the drawings, there is shown in
The device 10 comprises a proximal actuator portion or handle 12 and a distal sheath 14. Within and extending distally of the sheath 14 are a curved needle 16 and a movable straight needle 18. The handle 12 includes a straight needle slider 20 and a suture slider 22, the functions of which will be described below.
A suture needle 24 for use in the inventive device 10 is illustrated in
A procedure for passing suture using the device 10 will now be described. To begin the procedure, the practitioner holds and manipulates the handle 12. The passing end, or distal end of the device 10, as noted above, comprises the curved needle 16 and the movable straight needle 18. The practitioner receives the device 10 with suture pre-loaded into the straight needle 18. The tip of the device is passed through a cannula (not shown) into the joint space, which comprises the procedural site. As shown in
Once the straight needle is advanced, by operating the straight needle slider 20, moving it distally along a slot 42 in the handle 12 (
If desired, the practitioner may continue to pass suture through the tissue to create more pleats. When finished, the device 10 is removed from the joint space, and the suture is anchored by tying a knot or by securing it to a suture anchor.
A second needle grasper 48 is positioned within a lumen 49 in the curved needle 16. This needle grasper 48 also has a pair of grasper jaws 50 disposed on its distal end, which are also movable between an open and closed position, and are also resiliently biased to the open position. The jaws 50 are located within a larger diameter portion of the lumen 49, which permits the jaws 50 to spring open, as shown. The suture 34 passes out of the end of the straight needle 18, from the coil 32, and out of the joint space.
Once the needle grasper 36 in the straight needle releases the suture needle 24, the second needle grasper 48 is pulled to the right. The suture slider 22 on the handle 12 is utilized to move the suture graspers 36 and 48. The movement of the second needle grasper 48 proximally (to the right) pulls the suture needle through the tissue and into the curved needle. The coil 32 slides down the suture needle until it comes into contact with the collar 28, at which point it is pulled through the tissue, bringing the suture 34 with it.
There are many potential ways to attach suture to the suture needle. The coil 32, shown, is a simple method which can slide along the flexible wire 26 as the suture needle is passed through the tissue. However, the coil could be replaced by a number of other designs, such as a solid tube with a hole for tying the suture, a piece of heat shrink tubing which compresses the suture over the flexible wire, etc. The coil could alternatively be eliminated and the flexible wire pierced through the braided suture. Also, due to size constraints, the suture may be replaced by monofilament suture, suture smaller than #2, or metal wire. The other end of this wire would be attached to the suture that stays in the tissue (usually #2 high strength suture).
As shown in
It is to be understood that the invention as shown and described herein is potentially applicable to many different types of procedures requiring suture passing and the creation of one or more stitches in tissue. All of the terms used herein are descriptive rather than limiting, and many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention, which is to be limited only in accordance with the following claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3946740||15 Oct 1974||30 Mar 1976||Bassett John W||Suturing device|
|US4164225||28 Dec 1977||14 Aug 1979||Johnson & Lorenz, Inc.||Surgical suturing instrument|
|US4901721||2 Aug 1988||20 Feb 1990||Hakki Samir I||Suturing device|
|US4935027||21 Aug 1989||19 Jun 1990||Inbae Yoon||Surgical suture instrument with remotely controllable suture material advancement|
|US5015249||26 Dec 1989||14 May 1991||Nakao Naomi L||Endoscopic stapling device and method|
|US5336231||23 Nov 1992||9 Aug 1994||Adair Edwin Lloyd||Parallel channel fixation, repair and ligation suture device|
|US5403326||1 Feb 1993||4 Apr 1995||The Regents Of The University Of California||Method for performing a gastric wrap of the esophagus for use in the treatment of esophageal reflux|
|US5431666||24 Feb 1994||11 Jul 1995||Lasersurge, Inc.||Surgical suture instrument|
|US5665096 *||7 Mar 1995||9 Sep 1997||Yoon; Inbae||Needle driving apparatus and methods of suturing tissue|
|US6443963 *||26 Jul 2000||3 Sep 2002||Orthopaedic Biosystems, Ltd.||Apparatus and method for repairing or reattaching soft tissue|
|US6533795||11 Apr 2000||18 Mar 2003||Opus Medical, Inc||Dual function suturing apparatus and method|
|US6551330||21 Sep 2000||22 Apr 2003||Opus Medical, Inc.||Linear suturing apparatus and methods|
|US6618626||29 Aug 2001||9 Sep 2003||Hs West Investments, Llc||Apparatus and methods for protecting the axillary nerve during thermal capsullorhaphy|
|US6638286||16 Nov 2000||28 Oct 2003||Vascular Control Systems, Inc.||Doppler directed suture ligation device and method|
|US6770084||3 Dec 2002||3 Aug 2004||Opus Medical, Inc.||Suture capture device|
|US6893448||23 Oct 2002||17 May 2005||Arthrex, Inc.||Endoscopic capsular suture plication instrument and method|
|US6921361||23 Jul 2001||26 Jul 2005||Olympus Corporation||Endoscopic instrument for forming an artificial valve|
|US7063715||10 Jul 2003||20 Jun 2006||Olympus Corporation||Endoscopic suture apparatus|
|US7087064||15 Oct 2002||8 Aug 2006||Advanced Cardiovascular Systems, Inc.||Apparatuses and methods for heart valve repair|
|US7112208||7 Jun 2002||26 Sep 2006||Morris John K||Compact suture punch with malleable needle|
|US7118583||23 Oct 2002||10 Oct 2006||Arthrex, Inc.||Meniscal suturing instrument and method|
|US7166116||23 Jun 2003||23 Jan 2007||Ethicon, Inc.||Tissue grasper/suture passer instrument|
|US7232446||16 Jan 2003||19 Jun 2007||Farris Alex F||Pneumatic suture instrument|
|US7513904||15 Mar 2004||7 Apr 2009||Marlen Andreevich Sulamanidze||Surgical thread and cosmetic surgery method|
|US7918868||22 May 2007||5 Apr 2011||Scandius Biomendical, Inc.||Method and apparatus for meniscal repair|
|US8177795||21 Oct 2009||15 May 2012||Cayenne Medical, Inc.||Meniscal repair systems and methods|
|US8267948||24 Nov 2009||18 Sep 2012||Tyco Healthcare Group Lp||Method and apparatus for meniscal repair|
|US20020095199||29 Aug 2001||18 Jul 2002||Hs West Investments, Llc,||Apparatus and methods for protecting the axillary nerve during thermal capsullorhaphy|
|US20020128533||12 Mar 2001||12 Sep 2002||Barker Anthony T.||Stimulators and stimulating coils for magnetically stimulating neuro-muscular tissue|
|US20030078599||23 Oct 2002||24 Apr 2003||O'quinn Philip S.||Endoscopic capsular suture plication instrument and method|
|US20030083695||7 Jun 2002||1 May 2003||Morris John K.||Compact suture punch with malleable needle|
|US20030236535||6 May 2003||25 Dec 2003||Olympus Optical Co., Ltd.||Apparatus for ligating/suturing living tissues and system for resecting/suturing living tissues|
|US20040034371||18 May 2001||19 Feb 2004||Glen Lehman||Method of promoting tissue adhesion|
|US20040059352||18 Sep 2003||25 Mar 2004||Vascular Control Systems, Inc.||Doppler directed suture ligation device and method|
|US20040092968||5 Sep 2001||13 May 2004||Caro Nicholas C.||Scleral clip and procedures for using same|
|US20040260314||23 Jun 2003||23 Dec 2004||Lizardi Jose E.||Tissue grasper/suture passer instrument|
|US20080077162||5 Sep 2007||27 Mar 2008||Cayenne Medical, Inc.||Arthroscopic soft tissue plication systems and methods|
|US20100113873||6 Nov 2008||6 May 2010||Takayuki Suzuki||Suturing device and suturing system|
|US20100114123||22 Oct 2009||6 May 2010||Cayenne Medical, Inc.||Arthroscopic suture passing devices and methods|
|US20100280530||29 Apr 2010||4 Nov 2010||Wilson-Cook Medical Inc.||Medical systems, devices and methods for suturing perforations|
|US20110118757||22 Mar 2007||19 May 2011||Pierce Instruments, Inc.||Surgical end effector apparatus and method|
|US20110144666 *||17 Feb 2011||16 Jun 2011||A.M.I. Agency For Medical Innovations Gmbh||Surgical apparatus|
|US20130274769 *||26 Apr 2013||17 Oct 2013||P Tech, Llc||Deformable fastener system|
|WO1996027331A1||29 Feb 1996||12 Sep 1996||Inbae Yoon||Needle driving apparatus and methods of suturing tissue|
|WO1999003402A1||15 Jul 1998||28 Jan 1999||Yeung Teresa T||Partial to full thickness suture device and method for endoscopic surgeries|
|WO2001089370A2||18 May 2001||29 Nov 2001||C.R. Bard, Inc.||Method of promoting tissue adhesion|
|WO2008113076A2||17 Mar 2008||18 Sep 2008||Rhaphis Medical, Inc.||Limited access suturing devices, system, and methods|
|WO2009005527A1||3 Jul 2007||8 Jan 2009||Revolutionary Surgical Device, Llc||Methods and devices for continuous suture passing|
|WO2010019973A1 *||19 Aug 2008||25 Feb 2010||A.M.I. Agency For Medical Innovations Gmbh||Surgical device|
|1||Bradley et al. "Arthroscopic Treatment of Multidirectional Instability: Thermal Technique" in "Shoulder Arthroscopy" (edited by Tibone et al., Aug. 2003).|
|International Classification||A61B17/062, A61B17/06, A61B17/04|
|Cooperative Classification||A61B2017/0608, A61B2017/0609, A61B2017/06042, A61B17/0469, A61B2017/06104, A61B2017/06052, A61B2017/06009, A61B2017/0472, A61B17/0482, A61B17/0625|
|13 Jul 2015||AS||Assignment|
Owner name: CAYENNE MEDICAL, INC., ARIZONA
Free format text: RELEASE BY SECURED PARTY;ASSIGNORS:VENTURE LENDING & LEASING VI, INC.;VENTURE LENDING & LEASING VII, INC.;REEL/FRAME:036071/0863
Effective date: 20150519
|6 Aug 2015||AS||Assignment|
Owner name: CAYENNE MEDICAL, INC., ARIZONA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:NASON, KEVIN S.;REEL/FRAME:036272/0467
Effective date: 20100111